Omeprazole ............................................ 20 mg
Excipients.q.s ....................................1 capsule
Enteric capsule.
Box of 3 blisters x 10 capsules.
Bottle of 150 capsules.
Bottle of 100 capsules.
Omeprazole inhibits secretion of gastric acid and is considered to do so by reversibly blocking the enzyme of hydrogen/potassium adenosine triphosphatase, the so-called proton pump of the gastric parietal cells. Action of omeprazole is quick, prolonged, but reversible. Omeprazole has no effects on acetylcholine or histamine receptors. Maximum effect achieved within four days of treatment.
Absorption of omeprazole takes place in the small intestine and is usually completed within 3 - 6 hrs. The bioavailability is about 60%. Concomitant intake of food has no influence on the absorption. Omeprazole may improve its absorption and relative bioavailability by inhibiting the secretion of gastric acid. Omeprazole is highly bound (about 95%) to plasma proteins and distributed to the tissues, particularly to the gastric parietal cells. After repeated once-daily administration, the bioavailability increases to about 60%. Although the elimination half-life is short (about 40 minutes), the duration of action with regard to inhibition of acid secretion is longer allowing it to be used in single daily doses. Omeprazole is completely metabolised mainly in the liver. About 80% of an orally given dose is excreted in the urine and the remainder is found in the feces. The metabolites of omeprazole are mostly inactive but may interact with other medicines due to inhibition of cytochrome P450 enzyme. The pharmacokinetics of omeprazole is insignificantly changed in the elderly or in patients with renal impairment. In patients with impaired hepatic function, the bioavailability of omeprazole is increased and the clearance of omeprazole is decreased, but there is no drug accumulation or metabolites in the body.
The drug can induce certain adverse effects e.g., headache, dizziness; therefore, the drug should be taken with caution during driving or operating machinery.
Experimentally, omeprazole causes no deformity and toxicity to fetus. However, omeprazole should not be administered during pregnancy, particularly in the first trimester of pregnancy.
Omeprazole should not be administered to breast-feeding mothers.
Omeprazole may prolong the elimination of diazepam, phenytoin, and warfarin and certain drugs metabolised by the cytochrome P450 system. Omeprazole may enhance the plasma concentration of ciclosporin and the action of dicoumarol and antibiotics for H. pylori eradication.
Frequently: headache, drowsiness, dizziness, vomiting, nausea, constipation, abdominal distension.
Infrequently: insomnia, fatigue, sensation disorders, pruritus, urticaria, temporary increase in transaminase hepatic enzyme.
Rarely: sweating, peripheral oedema, hypoleukemia, thrombocytopenia, depression.
Inform your physician about any adverse effects occur during the treatment.
In the event of overdosage, only treating symptoms, no having specific drugs.
Store in dry places, not exceeding 30°C, protect from light.
Before receiving omeprazole therapy, the possibility of malignancy should be excluded since the drug may mask symptoms and delay diagnosis.
Gastroesophageal reflux disease. Gastric and duodenal ulcers. Zollinger-Ellison syndrome.
Hypersensitivity to any components of the drug.
Omeprazole should be orally taken 30 minutes before breakfast.
Treatment of reflux oesophagitis: The recommended dose is 20 - 40 mg (1 - 2 capsules) once daily within 4 - 8 weeks. A maintenance dose is 20 mg once daily.
Treatment of ulcers: Oral dose of 20 mg (1 capsule) once daily. In severe cases, doses of 40 mg (2 capsules) within 4 weeks in case of duodenal ulcer; within 8 weeks in case of gastric ulcer.
Treatment of Zollinger-Ellison syndrome: Oral dose of 60 mg (3 capsules) once daily. Doses more than 80 mg (4 capsules) should be divided and given twice daily.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
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